Dear ALLSTAT,

 

Jessica Todd is looking for a Statistical Consultant to join a Global Pharmaceutical company on an initial 6 month contract basis at their site based in the Home Counties.

 

The Statistics Consultant role is a technical role without direct line reports and reports into the Senior Statistics Manager for a Supply Division (i.e. PS or NP&GS). The job holder will be responsible for technical leadership of Statistics across their Supply Division and will be expected to direct the technical activities of small teams (3 – 8 people) comprising statisticians and members of the Statistics Community.

 

This role is critical to ensuring that reliable and quality data is generated about products, new and existing and processes, to provide good statistical practice and solutions to support regulatory requirements, customer and business priorities and to reduce cost of poor quality in manufacturing processes.

 

The GMS statistics service is continually evolving to ensure the provision of continued value to the GMS operation.

 

The role holder is required to drive a culture of statistical excellence in the efficient application of appropriate statistical methodology across their Supply Division. This may include:

- Leading and supporting cross-site/functional statistical projects under the sponsorship of senior managers/VPs in GMS

- Initiating and leading site projects

- Investigating new statistical methodologies and associated software

- Providing advice and guidance on the use of appropriate and advanced statistical methods and data analyses.

- Designing and implementing effective statistical solutions and standards throughout GMS in relation to assigned projects.

- Providing ongoing support and ensuring understanding of statistical methodology and limitations due to mathematical assumptions, appropriateness and quality of data.

- Designing and possibly delivering statistics training to Statisticians and non-Statisticians

- Improving business processes through the application of robust statistical methods, incorporating advanced/sophisticated methods where appropriate.

- Reviewing, amending and maintaining statistical processes.

- Keeping up to date with regulatory changes within Europe and USA.

- Providing support to the global Statistics community.

- Developing and actively participating in a Community of Practice and sharing best practice/learning with others to increase overall statistics capability within GMS.

 

Accountability:

• primary deliverables of role; it's scope; impact on strategy, policy, business or people relationships

 

- Identifies and develops, or manages development, of new statistical methods to meet business needs of the Supply Division and which may be appropriate for wider use within GMS.

- Contributes to the leadership of the GMS Statistical Community. Typically will lead a global sub communities setting statistical standards/good practice/global training materials

- Provides advanced specialised statistical support to the Statistics community, typically to sites without dedicated statistical resource. This includes supporting non-statisticians with statistical queries and advising on the appropriate use of techniques and software.

- The design and possible delivery of statistics training and the development of advanced training materials with examples for widespread use.

- Representing GMS within the broader outside professional statistical community e.g. professional bodies, academia, regulators etc.

- Responsible for advising on the correct detailed use of statistical software (e.g. STATISTICA, SAS) to undertake analyses using the methods on which he/she has expert knowledge. This advice may frequently be of global value outside of the statistical community.

- Advises and influences senior management/ managers on the use/introduction of new or improved statistical methods to increase organizational performance. (eg; deploying the most appropriate and efficient statistical methods are used in reaching decisions and understanding processes within the area of influence and speciality).

- Identifies supports and proactively drives continuous improvement initiatives using appropriate/innovative methods.

- Ensure the Supply Division is conversant with the latest improvements in methods and new applications of current methods in specialist statistical area, to ensure continued improvements to our processes.

- Leads and is accountable for delivery of one or more statistical projects, or the statistical elements within a scientific project.

- Reviews, amends and maintains processes, documentation and technologies to comply with changing regulatory requirements.

 

Complexity:

• degree of change & uncertainty; level of influencing required; degree of matrix working

- Interpreting statistical data from different unit operations and communicating findings in an appropriate and effective manner to ensure results, limitations of data and the business context are understood.

- Communicating and engaging with manufacturing and process experts, Stakeholders and Sponsors across GMS sites within their Supply Division as appropriate; from Operators to senior VP’s.

- Works with technical experts across GMS to understand statistics requirements and to optimize the use of statistical data capture and analysis.

- Initiates and actively participates in cross functional, cross site improvement and troubleshooting activities.

- Works with complex data in different forms, from diverse sources and analyses, interprets and makes recommendations / decisions.

- Collaborates at a GMS level in respect of sharing knowledge and good practice to standardize and enhance the overall statistically capability within the organization.

- Through a broad in-depth understanding of GMS ensures alignment of statistics projects, or statistics elements of larger GMS projects with the overall Vision and strategy of GMS (as defined in ‘One Direction’).

- Focused on delivering clear business benefits and considers a range of factors (eg; Manufacturing processes, assumptions, restrictions, diversity and accuracy of data, liability) in the appropriate selection of statistical tools and techniques.

- Considers impacts of statistical decisions on the business processes, broader impacts within GMS and in relation to regulatory requirements

 

 

Specialised Knowledge:

• breadth & depth across disciplines or functions; expertise in field required

Personal skills:

• Strong interpersonal, networking, and facilitation skills.

• Flexibility to work effectively across cultures/countries.

• Presentation skills and the ability to communicate via a range of media

• Problem solving skills

 

Essential Requirements:

• Degree in Statistics, MS or MSc in Statistics

• Active member of major professional statistical societies/associations (eg; ASA, RSS, Pharma CMC) together with professional contacts within universities’ statistical or process engineering departments.

• Experience of working in the pharmaceuticals or a related industry (eg. Petrochemical or Polymer).

• A good knowledge of appropriate statistical analytical software (e.g Statistica, SAS etc)

• Ability to lead and facilitate cross site and cross functional teams.

• Proven matrix management skills and ability to work with multiple interfaces.

• Proven ability to communicate and influence effectively all levels of management.

• Experience of communicating complex information in logical and simplified terms

• Experience of providing advice and guidance to Statisticians and non-statisticians in the selection and use of statistical methods

• Ability to support and coach others in the deployment of appropriate statistical methods and use of software.

• Ability to identify and manage key stakeholders and customer interfaces.

• Understanding of regulatory requirements, processes and impacts.

 

Desired requirements:

• PhD in an area relevant to statistics

• Chartered Statistician (UK only)

• Project management skills and ability to manage specific technology projects

• OE skills and experience of using methodologies (Green Belt)

• Knowledge of drug development processes

• Knowledge of MVA and it’s use within a manufacturing environment

 

For more information, please contact Jessica Todd on 01438 842976 or email [log in to unmask]

 

Jessica Todd BA
Trainee Consultant - Biometrics
CK Clinical Limited
9 High Street
Stevenage
SG1 3BG
DD: 01438 842976
T: 01438 743047
F: 01438 723800
W: www.ckclinical.co.uk / www.ckmedics.com

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